Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder

Brief description of study

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to
assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of
aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic
Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive
aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks

Detailed Study Description

Screening Phase: up to 42 days (consisting of a Screening Visit (V1), a washout period and
Interim Screening Visit (V1a) when applicable, and a Baseline Visit (V2). The Screening Phase
will serve multiple purposes: to allow for appropriate washout of prohibited medications; to
allow for review of screening data; to establish a pre-treatment baseline of key outcome
measures.

Treatment Phase: The duration of the treatment is 8 weeks. The purpose of the treatment phase
is to evaluate the efficacy, safety, tolerability and steady-state plasma trough
concentration of aripiprazole in the treatment of serious behavioral problems in children and
adolescents with a diagnosis of Autistic Disorder..

Safety Follow-up Phase: All subjects will be followed up for safety (adverse events) at Day
16 after the last medication via telephone.